Pronunciation:

var-EN-i-kleen

Brand Names:

• Chantix
• Chantix Starter Pack
• Chantix Starting Month Box
• Chantix Start Month Pak

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Smoking Cessation Agent

Uses of This Medicine:

Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of varenicline in children older than 16 years of age. Use is not recommended in children 16 years of age and younger. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varenicline in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving varenicline.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Angina (severe chest pain), history of or
• Heart attack, history of or
• Heart or blood vessel problems or
• Stroke, history of—May increase risk for more serious side effects.

• Depression, history of or
• Mental problems (eg, psychosis), history of or
• Seizures, or history of—Use with caution. May make these conditions worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. It is also important to participate in a stop-smoking program while you use this medicine. This will make it easier for you to quit smoking.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You should set a date to stop smoking. Start using varenicline 1 week before this date.

Your doctor may also tell you to start using this medicine anytime and then to stop smoking between days 8 and 35 of treatment.

You may be told to take this medicine for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take this medicine for 12 more weeks to help you keep off smoking.

Take this medicine after eating, and with a full glass of water.

If you are motivated to quit smoking and did not succeed treatment with this medicine previously, or if you returned to smoking after using varenicline, talk with your doctor about whether another course of varenicline treatment may be right for you.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • To stop smoking:
    • Adults and children 17 years of age and older—
      • Days 1 to 3: 0.5 milligram (mg) once a day.
      • Days 4 to 7: 0.5 mg 2 times per day.
      • Days 8 to end of treatment: 1 mg 2 times per day.
    • Children 16 years of age and younger—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks that you use this medicine. This will allow for changes in your dose and to help reduce any side effects. Blood and urine tests may also be needed to check for unwanted effects.

This medicine may increase the risk of having a heart attack, especially in patients with heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, pain in your legs when walking, sweating, or troubled breathing.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause serious types of allergic reactions, including angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing or swallowing, or chest tightness while you are using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause some people to become drowsy or dizzy, or to have problems with concentration. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Tell your doctor if you have nausea or sleeping problems (trouble sleeping, or unusual dreams) while you are using this medicine. The dose of this medicine may need to be adjusted.

While you are using this medicine be careful to limit the amount of alcohol that you drink.

Sleepwalking may occur while you are using this medicine. This can sometimes lead to a behavior that is harmful to you or other people, or to property. Check with your doctor right away if you start sleepwalking.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Anxiety

black, tarry stools

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody stools

blurred vision

burning feeling in the chest or stomach

chest pain or discomfort

chills

cold hands and feet

cold sweats

confusion

cool, pale skin cough

deep or fast breathing with dizziness

difficult or labored breathing

dizziness

dry mouth

fainting

fast, pounding, or irregular heartbeat or pulse

flushed, dry skin

fruit-like breath odor

headache

headache, severe and throbbing

increased hunger

increased thirst

increased urination

indigestion

loss of consciousness

nausea

nervousness

nightmares

noisy breathing

nosebleed

numbness of the feet, hands and around the mouth

pain or discomfort in the arms, jaw, back, or neck

pale skin

pounding in the ears

rapid weight gain

seizures

shakiness

slow heartbeat

slurred speech

stomach pain or upset

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tenderness in the stomach area

tightness in the chest

tingling of the hands or feet

tremor

troubled breathing with exertion

unexplained weight loss

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual weight gain or loss

vomiting

vomiting of blood or material that looks like coffee grounds

Rare

Agitation

bleeding gums

bloating

blood in the urine or stools

constipation

dark urine

decrease in height

decreased awareness or responsiveness

difficulty in swallowing

eye pain

feeling of fullness

fever

frequent urination

general feeling of illness

heartburn

hostility

increased sensitivity of the skin to sunlight

increased volume of pale, dilute urine

irritability

itching, skin rash

loss of appetite

mood changes

muscle pain, cramps, or twitching

numbness or tingling in the hands, feet, or lips

pain or burning in the throat

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on the skin

red, scaling, or crusted skin

redness or other discoloration of the skin

severe sleepiness

severe stomach pain

severe sunburn

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

uncontrolled eye movements

yellow eyes or skin

Incidence not known

Anger

anxiety

behavior changes

discouragement

feeling sad or empty

feelings of panic

irregular heartbeat

loss of interest or pleasure

mood swings

restlessness

seeing, hearing, or feeling things that are not there

sleepwalking

thoughts of killing oneself

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abnormal dreams

absence of menstruation

change in taste

diarrhea

difficulty having a bowel movement

difficulty in moving

excess air or gas in the stomach or bowels

joint pain or swelling

lack or loss of strength

loss of taste

muscle stiffness

painful menstruation

passing gas

toothache

trouble sleeping

Less common

Belching

body aches or pain

burning, dry, or itching eyes

continuing ringing or buzzing or other unexplained noise in the ears

decreased interest in sexual intercourse

discharge, excessive tearing

ear congestion

feeling of constant movement of self or surroundings

feeling of warmth

hearing loss

inability to have or keep an erection

increased appetite

increased urge to urinate during the night

loss in sexual ability, desire, drive, or performance

loss of voice

nightmares

redness in the joints

redness of the face, neck, arms and occasionally, upper chest

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

sensation of spinning

sleepiness or unusual drowsiness

sneezing

sore throat

stomach discomfort

stuffy or runny nose

transient, mild, pleasant aromatic odor

trouble concentrating

waking to urinate at night

Rare

Change in color vision

difficulty seeing at night

increased sensitivity of the eyes to sunlight

night blindness

seeing floating dark spots or material before the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.